Surgical method

ABSTRACT

A method for using a smaller diameter infusion sleeve that reduces the potential for heat buildup and also provides adequate irrigation flow.

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/011,417, filed Dec. 14, 2004, now U.S. Pat. No. 7,094,229B2, which is a continuation-in-part of U.S. patent application Ser. No.10/937,065, filed Sep. 9, 2004, now U.S. Pat. No. 7,066,923 B2.

BACKGROUND OF THE INVENTION

This invention relates generally to the field of cataract surgery andmore particularly to manipulation tools and irrigation sleeves used inphacoemulsification surgery.

The human eye in its simplest terms functions to provide vision bytransmitting light through a clear outer portion called the cornea, andfocusing the image by way of the lens onto the retina. The quality ofthe focused image depends on many factors including the size and shapeof the eye, and the transparency of the cornea and lens.

When age or disease causes the lens to become less transparent, visiondeteriorates because of the diminished light that can be transmitted tothe retina. This deficiency in the lens of the eye is medically known asa cataract. An accepted treatment for this condition is surgical removalof the lens and replacement of the lens function by an artificialintraocular lens (IOL).

In the United States, the majority of cataractous lenses are removed bya surgical technique called phacoemulsification. A typical surgicalhandpiece suitable for phacoemulsification procedures consists of anultrasonically driven handpiece, an attached cutting tip, and irrigatingsleeve and an electronic control console. The handpiece assembly isattached to the control console by an electric cable and flexibletubings. Through the electric cable, the console varies the power leveltransmitted by the handpiece to the attached cutting tip and theflexible tubings supply irrigation fluid to and draw aspiration fluidfrom the eye through the handpiece assembly.

The operative part of the handpiece is a centrally located, hollowresonating bar or horn directly attached to a set of piezoelectriccrystals. The crystals supply the required ultrasonic vibration neededto drive both the horn and the attached cutting tip duringphacoemulsification and are controlled by the console. The crystal/hornassembly is suspended within the hollow body or shell of the handpieceby flexible mountings. The handpiece body terminates in a reduceddiameter portion or nosecone at the body's distal end. The nosecone isexternally threaded to accept the irrigation sleeve. Likewise, the hornbore is internally threaded at its distal end to receive the externalthreads of the cutting tip. The irrigation sleeve also has an internallythreaded bore that is screwed onto the external threads of the nosecone.The cutting tip is adjusted so that the tip projects only apredetermined amount past the open end of the irrigating sleeve.

Recently, a modified phacoemulsification technique called “bimanual”phacoemulsification has been adopted by many surgeons. With the bimanualtechnique, the irrigation sleeve is removed from around theultrasonically drive tip. This allows for the small tip to be insertedinto the eye through a smaller incision. Irrigation fluid is supplied bya second irrigating tip. The second tip may include a manipulation tool.Additional information concerning traditional phacoemulsification andbimanual phacoemulsification is included in U.S. Patent Publication No.US 2003/0069594 A1. And in particular, Paragraphs [0036] through [0037]and FIGS. 6-8, which are incorporated herein by reference. As describedin this reference, the second instrument does not use an outer siliconeinfusion sleeve. Rather the shaft of the manipulation tool is eitherhollow with irrigation ports, or solid with a separate hollow irrigatingconduit containing irrigation ports. Without the outer silicone sleeve,sealing of the wound is minimal. This allows excessive irrigating fluidto escape out of the eye through the wound. Excessive wound leakage cancause shallowing of the anterior chamber, excessive turbulence andpremature removal of the protective viscoelastic material. Excessivewound leakage can also cause over-hydration of the wound tissue,possibly resulting in edema.

Recently, it has been suggested that traditional one-handedphacoemulsification can be conducted through a relatively small incisionby reducing the diameter of the phacoemulsification tip/sleeve. A secondirrigation/aspiration tip, with or without an attached manipulationtool, may also be used to provide addition irrigation and aspiration.Such an arrangement minimizes wound leakage, thereby helping to avoidover-hydration of the wound, low intraocular pressure, excessiveturbulence and premature removal of the viscoelastic material. Theannular gap between the phaco tip and sleeve is used as an irrigationfluid pathway. Irrigation ports are provided on the sides of the sleeveto direct irrigating fluid out of and away from the aspiration port.Reducing the diameter of the infusion sleeve also reduces the amount ofirrigation fluid that can enter the eye. Also, smaller diameter infusionsleeves are more likely to be compressed by the wound against theultrasonically vibrating tip, thereby increasing the amount of heat.

Therefore, a need continues to exist for a method of using a smallerdiameter irrigation sleeve that reduces the likelihood of excessive heatbuildup and provides adequate irrigation during cataract surgery.

BRIEF SUMMARY OF THE INVENTION

The present invention improves upon the prior art by providing a methodfor using a smaller diameter infusion sleeve that reduces the potentialfor heat buildup and also provides adequate irrigation flow.

Accordingly, one objective of the present invention is to provide anirrigation sleeve that fits around the shaft of the manipulation tooland seals the shaft.

Another objective of the present invention is to provide an irrigationsleeve that reduces or prevents the flow of irrigating fluid out of thesleeve from around the shaft.

These and other advantages and objectives of the present invention willbecome apparent from the detailed description and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial cross-section of the phacoemulsification andirrigation/aspiration tips that may be used with the present invention.

FIG. 2 is a schematic illustration of a phacoemulsification handpieceand irrigation/aspiration handpiece being used for a traditionalbi-manual phacoemulsification surgical procedure.

FIG. 3 is a schematic illustration of a phacoemulsification handpieceand irrigation handpiece being used for the bi-manualphacoemulsification surgical procedure of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

As seen in FIGS. 1 and 3, the method of the present invention isgenerally practiced using irrigation tip 10 and phacoemulsification tip12 simultaneously in what is called a “Bi-Manual” surgical technique.Irrigation tip 10 may be any conventional irrigation tip and may includeirrigation port 17 and flexible outer silicone sleeve 14 and inner tube16. Inner tube 16 may also be formed with hook 15 or some othermanipulation device. Space 18 between sleeve 14 and tube 16 defines apathway for irrigating solution to flow out port 20 and into thesurgical site. Port 17 can be used as an additional irrigation port, andirrigating solution may be expressed out of ports 17 and 20.Phacoemulsification tip 12 is of similar construction and generallycontains flexible outer silicone sleeve 22 and inner tube 24 defining afirst irrigating fluid path 26 that allows irrigating fluid to flow outof port 30. Inner tube 24 contains open distal end 28 allowing materialto be aspirated through inner tube 24. Preferably, phacoemulsificationtip 12 has a reduced overall diameter, on the order of 0.7 mm to 0.9 mm,and sleeve 22 has an outer diameter on the order of 1.4 mm to 1.8 mm.Such a small diameter permits an incision size of preferably less thanaround 2.4 mm in width, even more preferably less than around 2.2 mm inwidth, and even more preferably less than around 2.0 mm in width, andeven more preferably less than around 1.8 mm in width and mostpreferably less than around 1.6 mm in width. Alternatively, tip may be aliquefracturing tip similar to the AQUALASE® tip sold by AlconLaboratories, Inc., Fort Worth, Tex. and described more fully in U.S.Pat. No. 6,579,270 B2 (Sussman, et al.) at FIGS. 23 and 24 and column 7,lines 32-45, the contents of which being incorporated herein byreference.

As best seen in FIG. 2, in a traditional bimanual phacoemulsificationtechnique, irrigation/aspiration handpiece 100 is connected topressurized or elevated source of irrigation fluid 102 through tubing103. Ultrasound handpiece 104 is connected to aspiration pump 106through tubing 105 and to ultrasound driver 107 through cable 109.Ultrasound handpiece 104 is not connected to source 102 and does nothave any irrigation capabilities.

As seen in FIGS. 1 and 3, in use, irrigation handpiece 200, having tip10, is connected to pressurized or elevated source of irrigation fluid202 through tubing 203. Ultrasound handpiece 204, having tip 12, isconnected to aspiration pump 206 through tubing 205, to source 202through tubing 211 and fitting 208 and to ultrasound driver 207 throughcable 209. Accordingly, both handpiece 200 and handpiece 204 have acommon irrigation source and both provide an irrigation function.Irrigation tip 10 is held in one hand by the surgeon and used in aconventional manner to provide an irrigating fluid, such as a salinesolution, into eye 32 to help maintain the integrity of the eye andprevent anterior chamber collapse. Phacoemulsification tip 12 is held inthe other hand by the surgeon and is connected to a suitable ultrasoundhandpiece. One suitable handpiece is the INFINITI® system handpieceavailable commercially from by Alcon Laboratories, Inc., Worth, Tex.Phacoemulsification tip 12 is used to conduct a traditionalphacoemulsification technique during which an irrigating fluid, such asa saline solution, is introduced into eye 32 through fluid path 26 andport 30 and debris is aspirated from eye 32 through distal end 28 andinner tube 24. Such an arrangement prevents direct contact betweenvibrating inner tube 24.

In order to use a relative small diameter sleeve 22, the surgical systemand the operating parameters used on the surgical system must beadjusted to provide adequate infusion flow and reduce the potential forheat buildup at the operative site. For example, a surgical systemhaving a low compliance aspiration system may be used. By lowcompliance, a system that is capable of increasing vacuum from 0 mm Hgto 600 mm Hg in less than 3 seconds at a flow rate of 25 cc/minute maybe consider a low compliance system. Such a system is commerciallyavailable as the INFINTI® Vision System from Alcon Laboratories, Inc.,Fort Worth, Tex. Such a system will help to maintain a stable eye evenwhen sleeve 22 is used. To help prevent excessive heat build up, theinventors have found that when sleeve 22 is used, delivering energy inshort pulses rather than continuously and/or vibrating tip 12 in atwisting or torsional pattern rather than longitudinally helps to reduceheat build up.

This description is given for purposes of illustration and explanation.It will be apparent to those skilled in the relevant art that changesand modifications may be made to the invention described above withoutdeparting from its scope or spirit.

1. A surgical method, comprising the steps of: a) inserting anultrasonic tip of a phacoemulsification handpiece into an eye, theultrasonic tip having a hollow inner tube covered by an outer flexiblesleeve, the hollow inner tube allowing aspiration, a space between theinner tube and the outer sleeve creating a first irrigation fluid path,the outer sleeve being sized so as to permit the ultrasonic tip to passthrough an incision of less than 2.4 mm but larger than 1.6 mm in width;b) simultaneously inserting an irrigation tip of an irrigation handpieceinto the eye, the irrigation tip creating a second irrigation fluid pathinto the eye; c) ultrasonically vibrating the ultrasonic tip in shortpulses; and d) irrigating the eye with fluid from the first irrigationfluid path and the second irrigation fluid path.
 2. The method of claim1 wherein the incision is less than around 2.2 mm but larger than around1.6 mm in width.
 3. The method of claim 1 wherein the incision is lessthan around 2.0 mm but larger than around 1.6 mm in width.
 4. The methodof claim 1 wherein the incision is less than around 1.8 mm but largerthan around 1.6 mm in width.
 5. A surgical method, comprising the stepsof: a) inserting an ultrasonic tip of a phacoemulsification handpieceinto an eye, the ultrasonic tip having a hollow inner tube covered by anouter flexible sleeve, the hollow inner tube allowing aspiration, aspace between the inner tube and the outer sleeve creating a firstirrigation fluid path, the outer sleeve being sized so as to permit theultrasonic tip to pass through an incision of less than 2.4 mm butlarger than 1.6 mm in width; b) simultaneously inserting an irrigationtip of an irrigation handpiece into the eye, the irrigation tip creatinga second irrigation fluid path into the eye; c) ultrasonically vibratingthe ultrasonic tip in a torsional pattern; and d) irrigating the eyewith fluid from the first irrigation fluid path and the secondirrigation fluid path.
 6. The method of claim 5 wherein the incision isless than around 2.2 mm but larger than around 1.6 mm in width.
 7. Themethod of claim 5 wherein the incision is less than around 2.0 mm butlarger than around 1.6 mm in width.
 8. The method of claim 5 wherein theincision is less than around 1.8 mm but larger than around 1.6 mm inwidth.
 9. A surgical method, comprising the steps of: a) inserting anultrasonic tip of a phacoemulsification handpiece into an eye, theultrasonic tip having a hollow inner tube covered by an outer flexiblesleeve, the hollow inner tube allowing aspiration, a space between theinner tube and the outer sleeve creating a first irrigation fluid path,the outer sleeve being sized so as to permit the ultrasonic tip to passthrough an incision of less than 2.4 mm but larger than 1.6 mm in width;b) simultaneously inserting an irrigation tip of an irrigation handpieceinto the eye, the irrigation tip creating a second irrigation fluid pathinto the eye; c) ultrasonically vibrating the ultrasonic tip in shortpulses and/or in a torsional pattern; and d) irrigating the eye withfluid from the first irrigation fluid path and the second irrigationfluid path.
 10. The method of claim 9 wherein the incision is less thanaround 2.2 mm but larger than around 1.6 mm in width.
 11. The method ofclaim 9 wherein the incision is less than around 2.0 mm but larger thanaround 1.6 mm in width.
 12. The method of claim 9 wherein the incisionis less than around 1.8 mm but larger than around 1.6 mm in width.